The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Wireless Dr Imaging Option-wdr1.
| Device ID | K102615 |
| 510k Number | K102615 |
| Device Name: | WIRELESS DR IMAGING OPTION-WDR1 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John L Schmidt |
| Correspondent | John L Schmidt GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116732 | K102615 | 000 |
| 00840682116701 | K102615 | 000 |
| 00840682106139 | K102615 | 000 |